Quality Objective not being met - Nonconformance or Observation?

[somashekar]

Re: Who is responsible to set the Quality Objective?

By organizational design, it should be the department heads because they know their respective department best. In practice and especially in small organizations, the department heads may need assistance from the QMR to carry out this task (paper work). Who does it is not important. What's more important is that such objectives should be reconcilable to the company's quality policy.

I hope every head of department gets this correctly and align the objective to meet the company quality policy. Help will come from any corner only if the need to set, measure and meet objective is owned by the heads of departments or can also be termed as process owner.... Thanks harry.

 

[db]

I look at it this way. I have a goal (set by my doctor, actually) to lose 75 lbs. That does not mean that I should suddenly weigh 75 lbs less, but rather my behavior should be such as to move towards that goal. I also have to understand that a little thing called variation will undoubtedly show up. However, there should be a trend towards losing weight. If that trend is not meeting the plan, then I have to adjust my behavior to get back on track.

Now, it is MY responsibility to make sure I am moving towards the goal.

In an organization, it is the organization's responsibility to ensure that objectives are being met. I put this responsibility on the shoulders of top management. Department managers and the management rep need to be supporting the organization's (read top management's) plan to meet the objectives.

 

[howste]

I think that clause 8.2.3 of ISO 9001 provides the answer about what should happen if objectives aren't met:

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.

Not meeting the objectives (planned results) isn't necessarily a nonconformity, but there need to be actions taken.

 

[Sidney Vianna]

but there need to be actions taken.

as appropriate.

 

[howste]

as appropriate.

Yes, let's not forget the "weasel words." Many people believe that anytime the standards says "as appropriate," "when necessary," etc. it's automatically optional. As an auditor I'm obligated to ask for their justification for not taking action if there was no action taken.

 

[Jim Wynne]

Yes, let's not forget the "weasel words." Many people believe that anytime the standards says "as appropriate," "when neccesary," etc. it's automatically optional. As an auditor I'm obligated to ask for their justification for not taking action if there was no action taken.

Also, in this case, the "as appropriate" applies to a choice between correction and corrective action, not to whether action itself is necessary.

 

[JaneB]

Many times, objectives are not met for internal and external justifiable reasons. The critical thing is for the auditor to understand why the objective was not met, the level of awareness by management of the situation and what is being done about it.

Yes, completely so.

All Quality Objectives that did not meet its goal, should have a corresponding corrective action and improvement plans per quality objectives.

No, not true. Only if appropriate. There can be quite valid reasons for not meeting them.

If quality objective is not being met, then it is a nonconformity to your QMS

No, untrue. As above.

I think that clause 8.2.3 of ISO 9001 provides the answer about what should happen if objectives aren't met:
Not meeting the objectives (planned results) isn't necessarily a nonconformity, but there need to be actions taken.

Yes. One of those actions can be to consider the results, think about why the objective/s wasn't met... and decide nothing can or should be done about it in this case.

This kind of 'always a nonconformity' if not met thinking scares people about objectives. I'm not arguing in the case of, say, products that did'nt pass their acceptance criteria. But think of a project where, say quality objectives included delivering it on time and budget. But events occurred that made one of those things impossible to do (say, rain delayed a project). That's not an NC, and no actoin required, beyond perhaps considering whether enough time had beenallowed in schedule for weather delays. (OK, I know it's not a great example, best I could do).
Maybe it arises from some confusing of requirements (which one agrees to meet and must) with objectives - which are things one aims for but may perhaps not achieve.

 

[arin_23]

Nice coverage on the "tricky" topic so far.

To my opinion, if an organization has not been able to meet the quality objective,it is not a non conformity. As an auditor i would elicit further on the basis of selection of that quality objective and clause no. 5.4.2 i.e. quality management system planning.

If I observe that answers to both the above issues are in negative , then only I would raise a NC (that too if I am an internal auditor ).

Regards,

Arin

 

[joshua_sx1]

...a quality objective that has not been met should have reason why the organization failed to meet its own established objective... then the issuance of NC will be in accordance with the cause... e.g. if the object has not been met because of management prioritization has been changed or due to economic reasoning, it is a valid reason for not meeting an objective - it is useless to continue meeting an objective that will no longer give value to the organization... and on the other hand, if the objective has not been met because nobody do something to meet that objective and it has a negative impact on the performance of the organization, then there should be NC on this scenario...

 

[Polly Pure Bread]

...a quality objective that has not been met should have reason why the organization failed to meet its own established objective... then the issuance of NC will be in accordance with the cause... e.g. if the object has not been met because of management prioritization has been changed or due to economic reasoning, it is a valid reason for not meeting an objective - it is useless to continue meeting an objective that will no longer give value to the organization... and on the other hand, if the objective has not been met because nobody do something to meet that objective and it has a negative impact on the performance of the organization, then there should be NC on this scenario...

Scenario:

As a document controller my objective is to distribute new or revised document/s to copyholders 2 days prior to effectivity date. I was not able to meet the timeline due to justifiable reason. The case is two things:

1. one of our quality objectives
2. requirement - 4.2.3d to ensure that relevant versions of applicable documents are available at points of use

Nonconformity or not?